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Immunogenicity and Safety of Japanese Encephalitis Vaccine When Given With Measles-Mumps-Rubella (MMR) Vaccine

NCT02880865 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 628

Last updated 2020-10-14

Study results available
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Summary

This study aims to provide evidence that co-administration of measles-mumps-rubella vaccine (MMR) and live attenuated SA 14-14-2 Japanese encephalitis vaccine (CD-JEV) does not adversely affect immunogenicity or safety.

Conditions

Interventions

BIOLOGICAL

Live attenuated SA 14-14-2 Japanese Encephalitis vaccine

Single 0.5 mL dose of World Health Organization prequalified live, attenuated SA 14-14-2 JE vaccine manufactured by Chengdu Institute of Biological Products, Chengdu, China, administered by subcutaneous injection

BIOLOGICAL

Measles, mumps, rubella vaccine

Single 0.5 mL dose of live, attenuated measles-mumps-rubella vaccine (Schwarz measles virus, RIT 4385 mumps strain, and Wistar RA 27/3 rubella virus) manufactured by GlaxoSmithKline, Inc., administered by subcutaneous injection.

Sponsors & Collaborators

  • Research Institute for Tropical Medicine

    collaborator OTHER_GOV

  • Syneos Health

    collaborator OTHER

  • DFNet Research Inc.

    collaborator OTHER

  • PATH

    lead OTHER

Principal Investigators

  • Maria Rosario Capeding, MD · Research Institute for Tropical Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
9 Months
Max Age
9 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-10-13
Primary Completion
2017-05-19
Completion
2017-07-11

Countries

  • Philippines

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02880865 on ClinicalTrials.gov